Ear zap therapy: a new hope for aging hearts?
NCT ID NCT05230732
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial tests whether a gentle electrical stimulation applied to the ear—a technique called low-level transcutaneous vagus nerve stimulation—can help older adults with systolic heart failure. The study will compare daily one-hour sessions of real stimulation versus a sham (inactive) version over 12 weeks. Researchers will measure changes in exercise capacity, quality of life, inflammation, and blood vessel function to see if this non-drug approach could offer a new way to manage heart failure symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-level transcutaneous vagus nerve stimulation (LLTS) via a device applied to the ear
- What this could lead to
- If effective, this could offer a non-drug, at-home therapy to ease heart failure symptoms, boost exercise capacity, and improve quality of life in older adults.
- What could go wrong
- This is an early proof-of-concept study, so results may not be conclusive. The stimulation is experimental and may not work for everyone, and there is a small risk of discomfort or side effects from the device.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 158 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Systolic heart failure with EF \< or equal to 50%. Exclusion Criteria: 1. patients in overt congestive heart failure / recent acute myocardial infarction (\< 4 weeks) or Unstable angina 2. Active malignancy 3. unilateral or bilateral vagotomy 4. pregnant patients 5. End stage liver disease 6. history of recurrent vasovagal syncope, Sick sinus syndrome with no pacemaker, 2nd or 3rd degree AV block. 7. Significant hypotension (Blood pressure \< 90 mm Hg) secondary to autonomic dysfunction
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73117, United States
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